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Product NDC Code | 0037-6823 | ||||
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Drug Name | Proctofoam ns |
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Type | Brand | ||||
Active Ingredients |
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Route | RECTAL | ||||
Dosage Form | AEROSOL, FOAM | ||||
RxCUI drug identifier | 828365, 828367 |
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Application Number | M346 | ||||
Labeler Name | Meda Pharmaceuticals Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Pramoxine hydrochloride 1%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • place cap on container. Shake well before use • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissue or a soft cloth before application • dispense onto a clean tissue and apply externally to the affected area up to 5 times daily • children under 12 years of age: consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cetyl alcohol, glyceryl monostearate PEG-100 stearate blend, isobutane, methylparaben, polyoxyethylene 23 lauryl ether, polyoxyl 40 stearate, propane, propylene glycol, propylparaben, purified water, trolamine
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use for the temporary relief of pain and itching associated with hemorrhoids
Purpose
Information about the drug product’s indications for use.Purpose Local anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.PROCTOFOAM NS pramoxine hydrochloride PRAMOXINE HYDROCHLORIDE PRAMOXINE CETYL ALCOHOL GLYCERYL MONOSTEARATE PEG-100 STEARATE METHYLPARABEN LAURETH-23 POLYOXYL 40 STEARATE PROPYLENE GLYCOL PROPYLPARABEN WATER TROLAMINE ISOBUTANE PROPANE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel – 1% NDC 0037-6823-15 TAMPER EVIDENT FEATURE: Do not use if Meda Pharmaceuticals ® seal on ends of carton are broken or missing. proctofoam ® non-steroid pramoxine hydrochloride 1% hemorrhoidal foam For temporary relief of hemorrhoidal pain and itching STORE UPRIGHT NET WT. 0.53 OZ (15 g) Proctofoam Hydrochloride Foam Carton Label
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • store upright at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) • do not refrigerate • contents of the container are under pressure. Do not burn or puncture the aerosol container • do not store at temperatures above 49°C (120°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-888-350-1908 Distributed by: Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 © 2021 Viatris Inc. PROCTOFOAM is a registered trademark of Alaven Pharmaceutical LLC, a Viatris Company..
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only When using this product • do not exceed the recommended daily dosage unless directed by a doctor • do not put this product into the rectum by using fingers or any mechanical device or applicator • do not insert any part of the aerosol container into the rectum Stop use and ask a doctor if • rectal bleeding occurs • condition worsens or does not improve within 7 days • allergic reaction occurs to the ingredients in this product • symptom being treated does not subside • redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API